NA 311.15Recalls & reported problems
Synthes GmbH · TAP FOR 1.5MM CORTEX SCREWS 50MM · Class 2
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 4
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10886982187284), received between Jul 18, 2018 and Apr 16, 2020 — classified as 4 malfunctions.
The most frequently reported specific device problem is “Break” (4 reports).
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.
Most reported problems
Device problems
- Break4
Patient problems
- No Patient Involvement3
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 16, 2020Break; Break
IT WAS REPORTED THAT ON (B)(6) 2020, THE TWO (2) TAPS FOR CORTEX SCREWS WERE FOUND TO BE BROKEN DURING REVERSE LOGISTICS AUDIT OF RETURNED DEVICE AT MILLSTONE. THERE WAS NO PATIENT INVOLVEMENT. THIS COMPLAINT INVOLVES TWO (2) DEVICES. THIS IS REPORT 1 OF 2 FOR (B)(4).
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9968580 ↗MalfunctionApr 10, 2020Break; Break
IT WAS REPORTED THAT ON FEBRUARY 14, 2020, TWO (2) TAP FOR CORTEX SCREWS WERE DISCOVERED BROKEN DURING REVERSE LOGISTICS AUDIT OF RETURNED DEVICE AT MILLSTONE. THERE WAS NO PATIENT INVOLVEMENT AND NO ADDITIONAL INFORMATION IS AVAILABLE. THIS REPORT IS FOR ONE (1) TAP FOR 1.5MM CORTEX SCREWS 50MM. THIS IS REPORT 1 OF 2 FOR COMPLAINT (B)(4).
Patient problems: No Patient Involvement
MAUDE report 9950623 ↗MalfunctionApr 10, 2020Break; Break
IT WAS REPORTED THAT ON FEBRUARY 14, 2020, TWO (2) TAP FOR CORTEX SCREWS WERE DISCOVERED BROKEN DURING REVERSE LOGISTICS AUDIT OF RETURNED DEVICE AT MILLSTONE. THERE WAS NO PATIENT INVOLVEMENT AND NO ADDITIONAL INFORMATION IS AVAILABLE. THIS REPORT IS FOR ONE (1) TAP FOR 1.5MM CORTEX SCREWS 50MM. THIS IS REPORT 2 OF 2 FOR COMPLAINT (B)(4).
Patient problems: No Patient Involvement
MAUDE report 9950619 ↗MalfunctionJul 18, 2018Break; Break
IT WAS REPORTED THAT ON AN UNKNOWN DATE, A TAP WAS FOUND BROKEN DURING INSPECTION OF THE SET BY THE LOANERS DEPARTMENT. THERE WAS NO PATIENT INVOLVED. THIS REPORT IS FOR A TAP FOR 1.5MM CORTEX SCREWS 50MM. THIS IS REPORT 1 OF 1 FOR (B)(4).
Patient problems: No Patient Involvement
MAUDE report 7699857 ↗
Other DRIVER, WIRE, AND BONE DRILL, MANUAL devices
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- NA 5400007000Stryker Corporation · DRIVER, WIRE, AND BONE DRILL, MANUAL20 reports
- VSP System Mandible Cutting Guide3d Systems, Inc. · Driver, Wire, And Bone Drill, Manual13 reports
- VSP System Intermediate Surgical Splint3d Systems, Inc. · Driver, Wire, And Bone Drill, Manual6 reports
- NA 03.505.007Synthes GmbH · DRIVER, WIRE, AND BONE DRILL, MANUAL6 reports
- VSP System Fibula Cutting Guide with Implant Placement3d Systems, Inc. · Driver, Wire, And Bone Drill, Manual6 reports
- VSP System Fibula Cutting Guide3d Systems, Inc. · Driver, Wire, And Bone Drill, Manual5 reports
- NA 03.505.041Synthes GmbH · DRIVER, WIRE, AND BONE DRILL, MANUAL4 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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